Description

[SPECIMEN] Specimens obtained early during symptom onset will contain the highest viral titers; specimens obtained after five days of symptoms are more likely to produce negative results when compared to an RT-PCR assay. Inadequate specimen collection, improper specimen handling and/or transport may yield a falsely negative result; therefore, training in specimen collection is highly recommended due to the importance of specimen quality for generating accurate test results. Sample Collection Nasopharyngeal Swab Sample
Insert minitip swab with a flexible shaft (wire or plastic) through the nostril parallel to the palate (not upwards) until resistance is encountered or the distance is equivalent to that from the ear to the nostril of the patient, indicating contact with the nasopharynx. Swab should reach depth equal to distance from nostrils to outer opening of the ear. Gently rub and roll the swab. Leave swab in place for several seconds to absorb secretions. Slowly remove swab while rotating it. Specimens can be collected from both sides using the same swab, but it is not necessary to collect specimens from both sides if the minitip is saturated with fluid from the first collection. If a deviated septum or blockage creates difficulty in obtaining the specimen from one nostril, use the same swab to obtain the specimen from the othernostril. Oropharyngeal Swab Sample Insert swab into the posterior pharynx and tonsillar areas. Rub swab over both tonsillar pillars and posterior oropharynx and avoid touching the tongue, teeth, and gums. Sample Preparation After Swab specimens were collected, swab can be stored in extraction reagent provided with the kit. Also can be stored by immersing the swab head in a tube containing 2 to 3 mL of virus preservation solution (or isotonic saline solution, tissue culture solution, or phosphate buffer). Sample Transport and Storage Freshly collected specimens should be processed as soon as possible, but no later than one hour after specimen collection. Specimen collected may be stored at **8℃ for no more than *4 hours; Store at **0 â„ƒ for a long time, but avoid repeated freeze-thaw cycles. [SPECIMEN PREPARATION]

• Unscrew the lid of an extraction reagent. Add all of the specimen extraction reagent into an extraction tube, and put it on the work station.
• Insert the swab sample into the extraction tube which contains extraction reagent. Roll the swab at least 5 times while pressing the head against the bottom and side of the extraction tube.Leave the swab in the extraction tube for one minute.
• Remove the swab while squeezing the sides of the tube to extract the liquid from the swab. The extracted solution will be used as test specimen.
• Insert a dropper tip into the extraction tube tightly. 

• Remove the test cassette from the sealed pouch.1. Reverse the specimen extraction tube, holding the specimen extraction tube upright, transfer 3 drops (approximately **0μL) to the specimen well(S) of the test cassette, then start the timer. See illustrationbelow.
• Wait for colored lines to appear. Interpret the test resultsat *5 minutes. Do not read results after *0 minutes.